Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

NCT00555477 | Terminated Phase 2 Results DMC

• 2 other identifiers: UMCC 2007.044HUM 12443
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

Brief Summary

Women with hormone-receptor positive breast cancer are typically treated with hormone therapy as part of their treatment after surgery. In the past few years it has been found that treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women. Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are not effective in women who have functioning ovaries. Some women are premenopausal at the time they are diagnosed with breast cancer, but then stop having menstrual periods when they are treated with chemotherapy. It is unclear if these women can also be treated safely with aromatase inhibitors. In this clinical trial the researchers will try to answer this question. Women with hormone receptor positive breast cancer who become postmenopausal with chemotherapy will be invited to participate in this study. Each woman will be treated with one of the aromatase inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries do not start making estrogen. If her estrogen level remains low, then she will continued to be followed for 18 months. If the level increases to the level typically seen in premenopausal women, however, then she will stop taking part in this study. The study will also evaluate multiple factors that may help doctors predict who will tolerate the therapy without having their ovaries start making estrogen again. Some of the factors to be evaluated include other hormone levels (blood tests) as well as family history of early menopause (mother, sisters). In addition, changes in certain genes that affect how patients' bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients recover ovarian function. Overall, the purpose of the study is to determine which patients who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor treatment safely, and how often the patients' ovarian function needs to be tested during treatment.

Conditions

Breast Cancer

Keywords

premenopausal breast cancer with chemotherapy-induced ovarian failure

Outcome Measures

Primary Outcomes (1)

• The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy

  In part 1 ovarian function recurrence is defined as one estradiol value \>20 pg/ml or two consecutive values \>10 pg/ml. In part 2 ovarian function recurrence is defined as a \>75% increase in estradiol levels over prior if prior value was 15-30 pg/ml, or one estradiol value \>30 pg/ml, or three consecutive values \>20 pg/ml.

  12 months

Study Arms (1)

anastrozole

EXPERIMENTAL

Drug: anastrozole

Interventions

anastrozole DRUG

1 mg tablet by mouth once a day

Also known as: Arimidex

anastrozole

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To be eligible for this study:
• You must be at least 18 years of age and not older than 60 years of age
• You have breast cancer which was confined to the breast and lymph nodes under the arm, and have no evidence of cancer elsewhere
• You must have had surgical removal of your tumor, and if indicated, radiation therapy must have been completed or planned
• Your tumor must express estrogen and/or progesterone receptors
• You must have had a menstrual period within 6 months before starting chemotherapy for your breast cancer.
• You must have been treated with a chemotherapy regimen that includes cyclophosphamide (Cytoxan). Your menstrual periods must have stopped for at least 8 weeks starting during or after chemotherapy.

You may not qualify if:

• You are not eligible to participate in this study if:
• \. Your ovaries have been surgically removed, treated with radiation therapy, or if you are taking medications (Zoladex™ or Lupron™) to block the function of your ovaries.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (3)

Sidney Kimmel Comprehensive Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Dana-Farber Cancer Center

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Henry NL, Xia R, Banerjee M, Gersch C, McConnell D, Giacherio D, Schott AF, Pearlman M, Stearns V, Partridge AH, Hayes DF. Predictors of recovery of ovarian function during aromatase inhibitor therapy. Ann Oncol. 2013 Aug;24(8):2011-6. doi: 10.1093/annonc/mdt149. Epub 2013 Apr 23.

  PMID: 23613476 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Because of poor accrual, the trial was closed after 69 of a planned 150 patients were enrolled.

Results Point of Contact

• Title: Dr. Norah Lynn Henry
• Organization: University of Michigan Comprehensive Cancer Center

norahh@umich.edu

734-936-4991

Study Officials

• Norah L. Henry, M.D., Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 8, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2013
• Last Updated: June 19, 2014
• Results First Posted: June 19, 2014

Record last verified: 2014-05

Locations

US (3)